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Patient 1
(B)(4). INVESTIGATION - EVALUATION: A REVIEW OF THE DIMENSIONAL VERIFICATION, DOCUMENTATION, INSTRUCTIONS FOR USE (IFU), QUALITY CONTROL AND VISUAL INSPECTION OF THE RETURNED DEVICE WAS CONDUCTED DURING THE INVESTIGATION. THE DEVICE IS SHIPPED WITH AN INSTRUCTION FOR USE (IFU). IN THE IFU IT STATES: THIS CATHETER WILL NOT TRANSMIT THERMAL ENERGY ALONG ITS LIGHT FIBERS TO PATIENT TISSUE. ANY EXCESSIVE THERMAL DAMAGE FROM THE LIGHT SOURCE WILL MANIFEST AT THE CATHETER/LIGHT PLUG JUNCTION, AND WILL NOT BE TRANSMITTED ALONG THE CATHETER LENGTH. NOTE: START ILLUMINATION WITH THE LIGHT SOURCE AT THE LOWEST SETTING, AS MANY LIGHT SOURCES PRODUCT THERMAL ENERGY AT VARYING TEMPERATURES. THIS WILL LIMIT THE POSSIBILITY OF THERMAL DAMAGE AT THE CATHETER/LIGHT PLUG JUNCTION. IT IS INADVISABLE TO USE ANY LIGHT SOURCE AT ITS HIGHEST SETTING, UNLESS THE LIGHT SOURCE`S ACTUAL THERMAL ENERGY OUTPUT IS KNOWN. THE VISUAL INSPECTION OF THE RETURNED DEVICE REPORTED THAT THE DEVICE HAD 1 PLUG AND 2 CATHETERS. THE RED INK MARK CATHETER DOESN?T HAVE THE TEFLON SUPPORT SLEEVE. THE LENGTH OF THE CATHETER MEASURES 82 CM IN LENGTH. THE BLACK INK MARK CATHETER HAS THE TEFLON SUPPORT SLEEVE AND MEASURES 82.5 CM IN LENGTH. A VISUAL EXAMINATION NOTED THAT 8MM OF THE BLACK INK MARK FIBER IS MELTED INTO THE SUPPORT SLEEVE OF THE CATHETER. BOTH ENDS OF THE FIBER PLUG ASSEMBLY HAVE A MELTED APPEARANCE AND HAVE PULLED APART. THE FIBER APPEARS MELTED. BOTH CATHETERS WERE NOTICEABLY USED. THERE IS NO EVIDENCE TO SUGGEST THAT THE PRODUCT WAS NOT MADE TO SPECIFICATIONS. REVIEW OF DEVICE HISTORY AND NON-CONFORMANCES WAS NOT POSSIBLE AS THE LOT NUMBER WAS NOT AVAILABLE. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. IF THE RESULT OF THIS INVESTIGATION CHANGES A FOLLOW UP MDR WILL BE SUBMITTED.